ARS Pharmaceuticals (SPRY) Stifel 2024 Healthcare Conference summary

Product innovation and market opportunity

• neffy is the first needle-free, nasal epinephrine product approved for severe allergies, offering a solution to needle-related safety issues and patient anxiety, with a U.S. launch underway.

• Seven Orange Book-listed patents provide exclusivity until 2038, supported by a strong cash position, including a $145M upfront licensing deal with ALK for ex-U.S. rights.

• neffy addresses non-compliance and dissatisfaction among 80%-90% of current epinephrine users, targeting a multi-billion-dollar U.S. market and aiming to double the addressable patient base.

• The product's unique absorption enhancer, Intravail, enables safe, low-dose systemic delivery, with exposures within the therapeutic window of approved injectables.

• ALK partnership covers Europe, Canada, and other regions, with ALK projecting $425M peak sales in anaphylaxis alone, while U.S. remains the primary focus for commercialization.

Commercial strategy and launch progress

• U.S. launch is in early stages, with strong initial uptake across both dissatisfied current users and new patients who previously refused or did not refill prescriptions.

• Sales force of 118 targets half of U.S. epinephrine prescribers, with over 5,700 of 12,500 targets visited and a third already prescribing neffy.

• neffy Experience Program enables HCPs to trial the product, supporting positive physician feedback and accelerating adoption.

• Commercial coverage goals are north of 60% by month six and 80% by month twelve, with contracting underway with major payers and a $25 or less copay for most insured patients.

• Consumer marketing, including celebrity-driven campaigns and partnerships with advocacy groups, will ramp up as coverage and HCP familiarity increase.

Financial outlook and access

• Gross-to-net target is 50%, with payer negotiations supporting this assumption.

• Patient assistance program will remain in place for those needing financial help, expected to account for a single-digit percentage of total units sold.

• Cash price is $199, with insured patients paying a maximum $25 copay, undercutting the $40 average for generic autoinjectors.

• No first-year sales guidance provided yet; performance is being tracked via IQVIA data.